UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The Company has an innovative and broad pipeline of product candidates that it believes can overcome the deficiencies of current treatment options for a variety of urological conditions with a focus on uro-oncology. The lead product candidates, MITOGEL™ (mitomycin) urothelial gel, 0.4% and VESIGEL™ (mitomycin) urothelial gel, 0.18% , are proprietary formulations of the chemotherapy drug Mitomycin C, or MMC, a generic drug which is currently used off-label for urothelial cancer treatment in a water-based formulation as an adjuvant, post-surgery, therapy. The Company is developing our product candidates as chemoablation agents, which means they are designed to remove tumors by non-surgical means, to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial carcinoma, or UTUC, and low-grade bladder cancer. MITOGEL™ and VESIGEL™ are formulated using proprietary reverse thermally triggered hydrogel, or RTGel, technology. The Company believes that RTGel-based drug formulations provide for the sustained release of an active drug in various types of urothelial cancer without compromising the safety of the patient or interfering with the natural flow of fluids in the urinary tract. UroGen’s drug formulations are designed to achieve this by increasing the dwell time as well as the tissue coverage throughout the organ with the active drug.
The Company’s clinical stage pipeline includes VESIMUNE™ (imiquimod) , its proprietary immunotherapy product candidate for the treatment of carcinoma in situ of the bladder. VESIMUNE™ is a novel, liquid formulation of Imiquimod, a generic toll-like receptor 7, or TLR7, agonist.
In addition, BOTUGEL™ is a proprietary novel RTGel-based formulation of BOTOX® (onabotulinumtoxin A), a branded drug, that the company believes can potentially serve as an effective treatment option for patients suffering from overactive bladder. UroGen has licensed the worldwide rights to BOTUGEL™ to Allergan Pharmaceuticals International Limited, or Allergan, a wholly owned subsidiary of Allergan plc, which plans to commence a Phase 2 clinical trial of BOTUGEL™.